Overview
Results from a large late-stage clinical trial showed that combining Johnson & Johnson’s Erleada with conventional hormone-blocking therapy, given both before and after prostatectomy, substantially raised the likelihood of removing almost all detectable cancer at the time of surgery and lowered the chance of disease progression or death. The data, disclosed at the American Society of Clinical Oncology meeting in Chicago and tracking patients for over five years, involve more than 2,000 men judged to have high-risk localized or locally advanced prostate cancer and who were candidates for prostate gland removal.
Key efficacy findings
At surgery, 8.9% of patients who received the Erleada-plus-hormone regimen had little to no detectable cancer remaining in the prostate, compared with 1% of those treated with hormone therapy alone. The company reported the combination cut the risk of the cancer spreading or of death by 20% relative to hormone therapy alone.
Investigators also examined a longer course of therapy: Erleada plus hormone therapy given for a full year before and after surgery. Among men receiving that extended regimen, the median time before needing subsequent treatment exceeded six years, almost twice the interval seen in the hormone-only group. The year-long course also reduced the risk of recurrence and death by 29%, according to the trial data.
Clinical context
Erleada, the trade name for the androgen receptor pathway inhibitor apalutamide, blocks hormonal signaling that promotes prostate cancer growth. The drug was approved in the United States in 2018 and is already used alongside hormone therapy that suppresses testosterone production. According to Johnson & Johnson, about 40% of the roughly 330,000 people diagnosed with prostate cancer in the U.S. fall into a high-risk category. The company also said that nearly half of patients who receive current standard treatment - prostate-removal surgery and radiation - experience cancer recurrence and require additional therapy.
Expert commentary
Mary-Ellen Taplin, the trial’s lead researcher at Dana-Farber Cancer Institute in Boston, noted the lack of prior approvals in the setting studied: "No ARPIs are approved for localized high-risk prostate cancer with either surgery or radiation. So the (data) would be paradigm changing."
Mark Wildgust, Johnson & Johnson’s medical affairs lead for oncology, framed the results as a clear clinical benefit: "The patient benefit here is unequivocal. I think that the evidence is really showing that Erleada is adding something that we had not seen before."
Safety and next steps
Johnson & Johnson reported the safety profile for the combination therapy was consistent with earlier studies. Common side effects among those receiving the regimen included hot flushes, urinary incontinence and erectile dysfunction. The company said it plans to work with regulators to seek approvals for the combination therapy in earlier stages of prostate cancer on a global basis.
Implications
The trial’s findings could alter treatment approaches for men with high-risk localized or locally advanced prostate cancer, where surgery and radiation currently constitute standard care. The combination regimen’s effect on minimal residual disease rates at surgery, relapse timing and long-term outcomes reported in this trial formed the basis for the company’s stated regulatory outreach.
Note: Trial follow-up duration, patient counts, percentage outcomes, and safety signals in this article reflect the data as presented by the company and investigators at the meeting; approval for earlier-stage use has not been granted and remains subject to regulatory review.